Tylenol maker: Potential FDA label change ‘unsupported by scientific evidence’
Tylenol maker Kenvue has urged the Food and Drug Administration (FDA) to halt proposed safety label changes to acetaminophen after the Trump administration linked its use during pregnancy to autism.
In response to a citizen petition filed last month, the agency said the “extensive scientific evidence developed over many years” does not support a causal link between acetaminophen use during pregnancy and developmental disorders.
“Acetaminophen is one of the most studied drugs in history, and the scientific evidence regarding acetaminophen use during pregnancy and neurodevelopmental outcomes has been continuously evaluated by the FDA and industry for more than a decade,” Kenvu said.
Acetaminophen is the only pain reliever that is considered safe for pregnant women. The agency noted that adopting the change would be “arbitrary, capricious and against the law.”
“The labeling request is unsupported by scientific evidence and would represent an unexplained departure from the FDA’s long-standing position on acetaminophen in pregnancy,” Kenvu said.
The citizen petition was filed by the Informed Consent Action Network, an anti-vaccine nonprofit with close ties to Health Secretary Robert F. Kennedy Jr.
The petition was filed Sept. 22, the same day President Trump and Kennedy warned pregnant women against taking Tylenol at a White House news conference because of an unproven link to autism.
“Don’t take it. Fight like hell not to take it,” Trump said repeatedly, urging pregnant women to “tough it out” if they’re in pain.
The current label instructs people who are pregnant or breastfeeding to “consult a health professional before use.”
Kennevy said he reached out “to express his views about a link between acetaminophen and autism” after meeting with Kennedy and other HHS staff in early September.
The agency said it told Kennedy that the science does not support a causal link for pregnant women, nor does it support an association between acetaminophen and autism and attention-deficit hyperactivity disorder.
Although the FDA said it was going to add a warning about the possible link, federal officials sounded a softer tone.
In a letter to physicians, FDA Commissioner Marty Macari said “a causal relationship has not been established and there are conflicting studies in the scientific literature”.
